Tag Archives: Generic Drug User Fee Amendments

IGI Laboratories Announces 4th Quarter 2012 and Year End 2012 Results

By Business Wirevia The Motley Fool

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IGI Laboratories Announces 4 th Quarter 2012 and Year End 2012 Results

BUENA, N.J.–(BUSINESS WIRE)– IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based topical generic drug development and manufacturing company, announced its financial results for the fourth quarter and year ended December 31, 2012.

Fourth Quarter 2012 Highlights vs. 2011

  • Total Revenues of $2.3 million, increase of 10% over same quarter in 2011
  • Invested in the infrastructure of our commercialization strategy and successfully launched the first ever IGI label generic topical pharmaceutical products
  • Raised approximately $2.0 million in cash through the sale of treasury stock to fund the purchase of the topical pharmaceutical product econazole nitrate cream 1%
  • Net loss was $1.2 million and $0.5 million for the fourth quarter of 2012 and 2011
  • Net loss included research and development costs of $1.1 and $0.6 million in 2012 and 2011
  • Increase in research and development costs in the fourth quarter of 2012 over the same quarter last year due to additional costs related to approximately $0.3 million of Generic Drug User Fee Amendments of 2012 (GDUFA) fees required by the US FDA and $0.3 million of costs related to clinical studies

Year to Date 2012 Highlights vs. 2011

  • Total Revenues of $8.6 million in 2012, an increase of 10% over 2011
  • Net loss was $3.9 million in 2012 as compared to a net loss of $3.0 million in 2011
  • Net loss included research and development costs of $2.8 million and $2.2 million in 2012 and 2011
  • IGI has filed nine Abbreviated New Drug Applications (ANDAs) to date

IGI‘s President and Chief Executive Officer, Jason Grenfell-Gardner, stated, “I am extremely pleased with the progress IGI made in 2012. We launched the first ever IGI labeled topical pharmaceutical product; we filed five ANDAs with the US FDA, three for our own pipeline; we hired a proven …read more
Source: FULL ARTICLE at DailyFinance